Senior Production Process Engineer

<p>As Senior Production Process Engineer, you will lead and support the development, optimization, and validation of manufacturing processes for Nordberg Medical’s implantable Class III medical devices. This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques. You will play a crucial role in problem-solving and troubleshooting production issues while driving continuous improvement initiatives to enhance manufacturing capabilities while ensuring compliance with regulatory standards.<br/></p> <p><strong>Key Responsibilities </strong></p> <p>Your responsibilities will include, but not be limited to:</p> <p><strong>Process Design and Development: </strong><br/>• Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products. <br/>• Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes. <br/>• Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs). <br/> <strong><br/>Process Validation and Qualification: </strong><br/>• Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes. <br/>• Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements. <br/>• Analyze and document validation results, addressing any deviations or non-conformances. <br/>• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally. <br/> <strong><br/>Continuous Improvement and Optimization: </strong><br/>• Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality. <br/>• Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary. <br/>• Work closely with cross-functional teams, including R&amp;D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and project timelines. <br/>• Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards. <br/>• Collect and analyze production data to monitor process performance and identify areas for improvement. <br/>• Generate reports, metrics, and presentations for management, summarizing process performance, validation activities, and improvement initiatives. <br/> <strong><br/>Regulatory Compliance and Documentation: </strong><br/>• Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines. <br/>• Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities. <br/>• Participate in audits and regulatory inspections, providing technical support and documentation as required. <br/> <strong><br/>Equipment Management and Maintenance: </strong><br/>• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally. <br/>• Support the installation and validation of new equipment, ensuring it meets process requirements and regulatory standards.</p> <ol><ul> </ul> </ol> <ul> </ul> <p><strong>Required Experience &amp; Qualifications<br/></strong></p> <ul> <li>Around 5-8 years of experience in process engineering, within the pharmaceutical or medical device industry provided experience with at least Class III products.</li><li>Bachelor’s degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master’s degree is a plus.</li><li>Proficiency in process design, documentation and validation methodologies, including IQ/OQ/PQ.</li><li>Strong understanding of GMP, ISO13485, FDA 21 and other applicable regulatory requirements.</li><li>Experience with pharmaceutical cleanroom operations �� Class A to C.</li><li>Fluency in English (verbal and written). </li> </ul> <p><strong>Beneficial Qualifications </strong></p> <ul> <li>Experience of freeze drying processes in the pharmaceutical industry, preferably EtO. </li><li>Experience of sterilization processes in the pharmaceutical industry, preferably E-beam.</li><li>Experience with statistical process control (SPC), Design of Experiments (DOE), and root cause analysis.</li> <li>Familiarity with CAD software and process simulation tools.</li> <li>Advanced skills in data analysis and reporting.</li> </ul> <p><strong>Personality </s